Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by Walter Reed Army Medical Center. Recruitment status was Recruiting

First Received on December 4, 2007. No Changes Posted

Sponsor:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00567411

Purpose

The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.

Condition	Intervention
Glaucoma Ocular Hypertension	Drug: brimonidine 0.1% Drug: Apraclonidine 0.5%

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine 4-Aminoclonidine Brimonidine tartrate Apraclonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

Postoperative IOP [ Time Frame: 1 hour and 1 week post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall IOP reduction post SLT [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
Active Comparator: I Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT	Drug: Apraclonidine 0.5% 1 drop applied 1 hour prior to SLT
Active Comparator: A Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT	Drug: brimonidine 0.1% 1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

Detailed Description:

This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female, at least 18 years of age
Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
Ocular Hypertension requiring lowering of IOP
ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

inability to understand and provide informed consent to participate in this study
inability/unwillingness to follow study instructions and complete all required visits
Documented allergy to either brimonidine or iopidine
Angle Closure Glaucoma
Congenital/Juvenile Glaucoma
Neovascular Glaucoma
Active uveitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567411

Contacts

Contact: Vladimir S Yakopson, MD

202-782-6965

vladimir.yakopson@na.amedd.army.mil

Locations

United States, District of Columbia
Walter Reed Army Medical Center	Recruiting
Washington, District of Columbia, United States, 20307
Contact: Vladimir S Yakopson, MD 202-782-6965 vladimir.yakopson@na.amedd.army.mil
Sub-Investigator: William Wilson, MD

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators

Principal Investigator:

Vladimir S Yakopson, MD

Walter Reed AMC

More Information

No publications provided

Responsible Party:	Vladimir S Yakopson, MD, Ophthalmology Service, Department of Surgery, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00567411 History of Changes
Other Study ID Numbers:	WRAMC WU # 06-23016
Study First Received:	December 4, 2007
Last Updated:	December 4, 2007
Health Authority:	United States: Federal Government; United States: Human Use Committee

Keywords provided by Walter Reed Army Medical Center:

Glaucoma
Laser
laser trabeculoplasty
selective laser trabeculoplasty
intraocular pressure

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Apraclonidine
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012